Renal LithiasisKARLITHONCT03437057
Maintenance of an Antiaggregation by Acetylsalicylic Acid, While a Extracorporeal Lithotripsy Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study
A study testing acetylsalicylic acid (below or equal to) 250 mg in people with Renal Lithiasis and Antiplatelet, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Background/Rationale for the study: Lithiasis pathology is increasingly common because of the change in our lifestyle and our food. Thus, we hold a prevalence for urinary lithiasis 10% in France currently including 13% of the male population and 6% of the female population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Lithiasis, Antiplatelet, Hematoma
- What is being tested?
- acetylsalicylic acid (below or equal to) 250 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2018to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 yo patients
- Patients with 1 renal lithiasis (at least) requiring treatment with extracorporeal lithotripsy
- Patients taking Kardégic 75 (monotherapy
Who cannot join
- Patients with known (or previously known) bleeding disorders on the pre-treatment assessment
- Patients with anticoagulant therapy or other anti-aggregating therapy (eg Kardegic at 75mg, AVK, NACO, LMWH, HNF, P2Y12 inhibitor)
- Patients with another contrindication to the ECL.
- Patients with prescription of more than the outset 1 ECL session
- Tutelage, curatorship, justice safeguarding, deprived of liberties, unaffiliated SS, impaired comprehension abilities, pregnant and lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, 04 73 75 49 63, promo_interne_drci@chu-clermontferrand.fr
Laurent GUY, MD
About this study
Official title: Maintenance of an Antiaggregation by Acetylsalicylic Acid, Less or Equal to 250mg While a Extracorporeal Lithotripsy (ECL) Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study
Background/Rationale for the study:
Lithiasis pathology is increasingly common because of the change in our lifestyle and our food. Thus, we hold a prevalence for urinary lithiasis 10% in France currently including 13% of the male population and 6% of the female population.
Read more
The formation of urinary lithiasis is the result of a complex mechanism involving factors anatomical and infectious metabolics. They are classified according to their size, topography and composition.
The treatment of urinary lithiasis has changed dramatically in recent years. The recommendations of the French Urology Association (AFU) for the management of kidney stones and ureteral of the adult of 2004 give a certain place to the treatment by extracorporeal lithotripsy (ECL).
The ELC is indicated for the first purpose for lithiasis ureteral or renal lithiasis of less than 20 mm, whether or not associated with the setting up of a JJ stent. For kidney stones of more than 20 mm or complex or Coralliformes, the ECL can be associated with treatment with percutaneous nephrolithotomy. In addition, the ECL is indicated in case of residual cholelithiasis 3 months after a first treatment whatsoever.
It is found, as the main complication of the ECL, a risk of the appearance of Hematomas under capsular, peri-renal and intra-parenchymatous. Its prevalence is estimated to be between 6.2% and 13% according to studies.
ACETYLSALICYLIC ACID less or equal to 250 mg is the usual dosage of aspirin (for the adult), the Marketing Autorisation recognises in secondary prevention after a first myocardial or cerebral ischemic attack related to atherosclerosis. It entrains a reduction mortality and morbidity of cardiovascular causes.
Acetylsalicylic acid is currently being stopped 5 to 7 days before the ECL. The interest of maintaining the Acetylsalicylic acid is:
- A simplification of the management of patients under on acetylsalicylic acid below (or equal to) 250 mg (No modification of Treatment to be implemented)
- A cardiovascular risk decreased by maintaining their initial treatment without any modification.
Main objective:
Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis, on a 15-day scan, in patients under on acetylsalicylic acid below (or equal to) 250 mg not stopped
Secondary objectives:
Evaluation of the efficacy of treatment with lithotripsy (Stone free, fragments Minimal residuals) Evaluation of the proportion of hematuria macroscopic post lithotripsy in Patients under on acethylsalicylic acid not stopped. Evaluate the rate of post-ECL complications requiring treatment, Analgesic, obstructive pyelonephritis.
Evaluate post-ECL pain due to hematoma or lithiasis migration Evaluation of the evolution of renal function post session of Lithotripsy on the patients under acethylsalicylic acid not stopped.
Type of Study: Interventional study, prospective, mono centric, single-arm
Read the detailed description
Before the ECL:
Patients will be recruited during the urology consultation prior to the lithotripsy for kidney stones Kidneys (JJ stent in place or not) using an uninjected abdominal-pelvic or ultrasound scanner Renal coupled to a AUSP (urinary tree without preparation). ECL is an Unbody method that allows the calculation to be fragmented using shock waves Generated by a lithotripter. It will be given to them, after explanation of this method by the doctor during the consultation, a AFU information sheet on the ECL explaining its steps, possible complications, its follow-up.
After checking the inclusion and non-inclusion criteria, patients will be programmed to ECL without prior stop of acethylsalicylic acid.
At the ECL session:
Evaluation of blood pressure before the session and at the end. Medical history and treatment will be notified in the patient file Verification of blood balance (coagulation, renal function) and urinary (BU and ECBU) Evaluation of pain by analog visual scale (AVS) before and during the session. Notification of possible symptoms (adverse reactions = AR) in the medical file. Prescription of analgesics as well as blood balance and revaluation scanner at D15 Taking a post-ECL appointment with the reference urologist at D23 (+-2days)
After the ECL session: 3-week post-ECL Consultation:
Pain Assessment (AVS) Evaluation of the effectiveness of the ECL (stone clearance)
Reading of the scanner performed at D15 in search of a hematoma "(the scanner will also be replayed from systematically by the prescriber or a urologist of the service looking for a hematoma and the level of efficacy of the ECL + control of the blood balance in search of a inflammatory/infectious/anemia/renal function Chronology of the essay:
Duration of study estimated at: 5 years Start date of study (first patient included): 01/2018 End Date (end of follow-up of the last patient of the study): 01/2023 Total duration of participation in the study for the patient: 5 to 6 weeks The end-of-study date shall be transmitted to the competent authority and the MPC within 90 days.
If the study is to stop prematurely, the information will be transmitted within a period of 15 days The competent authority and the MPC. Main judgement criterion: Proportion of patients with renal hematoma when performing of lithotripsy for renal lithiasis, on a 15-day scanner.
Number of topics: 300 based on a 4-step sequential plan of Fleming type
Inclusion criteria:
Patients over 18 years of age benefiting from the social security scheme Patients with at least one renal lithiasis requiring treatment with extracorporeal lithotripsy (ECL)
Non-inclusion criteria:
Coagulation disorder known or discovered on the pre-therapeutic balance sheet Associated anticoagulant therapy. Presence of another contraindications to the ECL.
Conduct of the study:
Study is carried out in current practice at the CHU of Clermont Ferrand in the Department of Urology.
The patient will be seen in consultation by the urologist who shall prescribe the Lithotripsy sessions, inform him about the of the session and will provide him a AFU information sheet concerning the stages of the session, and then, prescribe a blood test to be presented to the lithotriptor on the day of the examination. Not additional accommodation to plan. The patient will return 3 weeks after the ECL session for his evaluation with the urologist. He will have previously completed a blood check and a 15-day scan of the lithotripsy session (instead of about 3 weeks usually).
Benefits and risks of this study:
Simplify patient management under acethylsalicylic acid. Decrease in cardiovascular risk by maintaining the acethylsalicylic acid. Increase of the risk of post-ECL hematoma
- Conditions
- Renal Lithiasis, Antiplatelet, Hematoma
- Being tested
- acetylsalicylic acid (below or equal to) 250 mg
- Keywords
- ECL, Hematoma, Antiplatelet
- Medical subject headings
- Nephrolithiasis, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic acid (below or equal to) 250 mgOther
Prospective single-arm study to estimate the risk of renal hematoma when performing a session of lithotripsy for renal lithiasis, on a 15-day scanner, in patients treated with acetylsalicylic acid not suspended.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with acethylsalicylic acid 250 mg | Experimental | Prospective single-arm study to estimate the risk of renal hematoma when performing a session of lithotripsy for renal lithiasis, on a 15-day scanner, in patients treated with acetylsalicylic acid not suspended. Receives: Other: acetylsalicylic acid (below or equal to) 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis
Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis, on a 15-day scan, in patients under acetylsalicylic acid (below or equal to 250mg) not stopped
Measured: at 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start8 Jan 2018
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Renal LithiasisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlène GUANDALINO, MD, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437057
- Sponsor's protocol ID
- RBHP_2017_GUANDALINO
- Other IDs
- 2017- A01453-50
- Acronym
- KARLITHO
- Status last verified
- Jan 2025
- First submitted
- 5 Feb 2018
- Last updated
- 17 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Donsimoni R, Hennequin C, Fellahi S, Troupel S, Moel GL, Paris M, Lacour B, Daudon M. New aspects of urolithiasis in France. GERBAP: Groupe d'Evaluation et de Recherche des Biologistes de l'Assistance Publique des Hopitaux de Paris. Eur Urol. 1997;31(1):17-23.
PubMed 9032529Bihl G, Meyers A. Recurrent renal stone disease-advances in pathogenesis and clinical management. Lancet. 2001 Aug 25;358(9282):651-6. doi: 10.1016/S0140-6736(01)05782-8.
PubMed 11530173Daudon M, Dore JC, Jungers P, Lacour B. Changes in stone composition according to age and gender of patients: a multivariate epidemiological approach. Urol Res. 2004 Jun;32(3):241-7. doi: 10.1007/s00240-004-0421-y. Epub 2004 May 4.
PubMed 15127165Streem SB, Yost A, Mascha E. Clinical implications of clinically insignificant store fragments after extracorporeal shock wave lithotripsy. J Urol. 1996 Apr;155(4):1186-90.
PubMed 8632527Tolley DA. Consensus of lithotriptor terminology. World J Urol. 1993;11(1):37-42. doi: 10.1007/BF00182170.
PubMed 8490666Candau C, Saussine C, Lang H, Roy C, Faure F, Jacqmin D. Natural history of residual renal stone fragments after ESWL. Eur Urol. 2000 Jan;37(1):18-22. doi: 10.1159/000020093.
PubMed 10671779Raza A, Turna B, Smith G, Moussa S, Tolley DA. Pediatric urolithiasis: 15 years of local experience with minimally invasive endourological management of pediatric calculi. J Urol. 2005 Aug;174(2):682-5. doi: 10.1097/01.ju.0000164749.32276.40.
PubMed 16006948Badawy AA, Saleem MD, Abolyosr A, Aldahshoury M, Elbadry MS, Abdalla MA, Abuzeid AM. Extracorporeal shock wave lithotripsy as first line treatment for urinary tract stones in children: outcome of 500 cases. Int Urol Nephrol. 2012 Jun;44(3):661-6. doi: 10.1007/s11255-012-0133-0. Epub 2012 Feb 16.
PubMed 22350835Rodrigues Netto N Jr, Longo JA, Ikonomidis JA, Rodrigues Netto M. Extracorporeal shock wave lithotripsy in children. J Urol. 2002 May;167(5):2164-6.
PubMed 11956471Ather MH, Noor MA. Does size and site matter for renal stones up to 30-mm in size in children treated by extracorporeal lithotripsy? Urology. 2003 Jan;61(1):212-5; discussion 215. doi: 10.1016/s0090-4295(02)02128-3.
PubMed 12559298Al-Busaidy SS, Prem AR, Medhat M. Pediatric staghorn calculi: the role of extracorporeal shock wave lithotripsy monotherapy with special reference to ureteral stenting. J Urol. 2003 Feb;169(2):629-33. doi: 10.1097/01.ju.0000047231.36474.57.
PubMed 12544330Ozgur Tan M, Karaoglan U, Sozen S, Bozkirli I. Extracorporeal shock-wave lithotripsy for treatment of ureteral calculi in paediatric patients. Pediatr Surg Int. 2003 Aug;19(6):471-4. doi: 10.1007/s00383-003-0961-1. Epub 2003 May 8.
PubMed 12736749Onal B, Demirkesen O, Tansu N, Kalkan M, Altintas R, Yalcin V. The impact of caliceal pelvic anatomy on stone clearance after shock wave lithotripsy for pediatric lower pole stones. J Urol. 2004 Sep;172(3):1082-6. doi: 10.1097/01.ju.0000135670.83076.5c.
PubMed 15311043Ozgur Tan M, Karaoglan U, Sen I, Deniz N, Bozkirli I. The impact of radiological anatomy in clearance of lower calyceal stones after shock wave lithotripsy in paediatric patients. Eur Urol. 2003 Feb;43(2):188-93. doi: 10.1016/s0302-2838(02)00492-x.
PubMed 12565778Demirkesen O, Onal B, Tansu N, Altintas R, Yalcin V, Oner A. Efficacy of extracorporeal shock wave lithotripsy for isolated lower caliceal stones in children compared with stones in other renal locations. Urology. 2006 Jan;67(1):170-4; discussion 174-5. doi: 10.1016/j.urology.2005.07.061.
PubMed 16413356
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance of an Antiaggregation by Acetylsalicylic Acid, Less or Equal to 250mg While a Extracorporeal Lithotripsy (ECL) Session on a Kidney Stone is Perfomed: Comparative Unicentric Prospective Study
- ClinicalTrials.gov ID
- NCT03437057
- Acronym / sponsor ID
- KARLITHO / RBHP_2017_GUANDALINO
- Conditions
- Renal Lithiasis, Antiplatelet, Hematoma
- Keywords
- ECL, Hematoma, Antiplatelet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background/Rationale for the study:
Lithiasis pathology is increasingly common because of the change in our lifestyle and our food. Thus, we hold a prevalence for urinary lithiasis 10% in France currently including 13% of the male population and 6% of the female population.
The formation of urinary lithiasis is the result of a complex mechanism involving factors anatomical and infectious metabolics. They are classified according to their size, topography and composition.
The treatment of urinary lithiasis has changed dramatically in recent years. The recommendations of the French Urology Association (AFU) for the management of kidney stones and ureteral of the adult of 2004 give a certain place to the treatment by extracorporeal lithotripsy (ECL).
The ELC is indicated for the first purpose for lithiasis ureteral or renal lithiasis of less than 20 mm, whether or not associated with the setting up of a JJ stent. For kidney stones of more than 20 mm or complex or Coralliformes, the ECL can be associated with treatment with percutaneous nephrolithotomy. In addition, the ECL is indicated in case of residual cholelithiasis 3 months after a first treatment whatsoever.
It is found, as the main complication of the ECL, a risk of the appearance of Hematomas under capsular, peri-renal and intra-parenchymatous. Its prevalence is estimated to be between 6.2% and 13% according to studies.
ACETYLSALICYLIC ACID less or equal to 250 mg is the usual dosage of aspirin (for the adult), the Marketing Autorisation recognises in secondary prevention after a first myocardial or cerebral ischemic attack related to atherosclerosis. It entrains a reduction mortality and morbidity of cardiovascular causes.
Acetylsalicylic acid is currently being stopped 5 to 7 days before the ECL. The interest of maintaining the Acetylsalicylic acid is:
- A simplification of the management of patients under on acetylsalicylic acid below (or equal to) 250 mg (No modification of Treatment to be implemented)
- A cardiovascular risk decreased by maintaining their initial treatment without any modification.
Main objective:
Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis, on a 15-day scan, in patients under on acetylsalicylic acid below (or equal to) 250 mg not stopped
Secondary objectives:
Evaluation of the efficacy of treatment with lithotripsy (Stone free, fragments Minimal residuals) Evaluation of the proportion of hematuria macroscopic post lithotripsy in Patients under on acethylsalicylic acid not stopped. Evaluate the rate of post-ECL complications requiring treatment, Analgesic, obstructive pyelonephritis.
Evaluate post-ECL pain due to hematoma or lithiasis migration Evaluation of the evolution of renal function post session of Lithotripsy on the patients under acethylsalicylic acid not stopped.
Type of Study: Interventional study, prospective, mono centric, single-arm
Detailed description
Before the ECL:
Patients will be recruited during the urology consultation prior to the lithotripsy for kidney stones Kidneys (JJ stent in place or not) using an uninjected abdominal-pelvic or ultrasound scanner Renal coupled to a AUSP (urinary tree without preparation). ECL is an Unbody method that allows the calculation to be fragmented using shock waves Generated by a lithotripter. It will be given to them, after explanation of this method by the doctor during the consultation, a AFU information sheet on the ECL explaining its steps, possible complications, its follow-up.
After checking the inclusion and non-inclusion criteria, patients will be programmed to ECL without prior stop of acethylsalicylic acid.
At the ECL session:
Evaluation of blood pressure before the session and at the end. Medical history and treatment will be notified in the patient file Verification of blood balance (coagulation, renal function) and urinary (BU and ECBU) Evaluation of pain by analog visual scale (AVS) before and during the session. Notification of possible symptoms (adverse reactions = AR) in the medical file. Prescription of analgesics as well as blood balance and revaluation scanner at D15 Taking a post-ECL appointment with the reference urologist at D23 (+-2days)
After the ECL session: 3-week post-ECL Consultation:
Pain Assessment (AVS) Evaluation of the effectiveness of the ECL (stone clearance)
Reading of the scanner performed at D15 in search of a hematoma "(the scanner will also be replayed from systematically by the prescriber or a urologist of the service looking for a hematoma and the level of efficacy of the ECL + control of the blood balance in search of a inflammatory/infectious/anemia/renal function Chronology of the essay:
Duration of study estimated at: 5 years Start date of study (first patient included): 01/2018 End Date (end of follow-up of the last patient of the study): 01/2023 Total duration of participation in the study for the patient: 5 to 6 weeks The end-of-study date shall be transmitted to the competent authority and the MPC within 90 days.
If the study is to stop prematurely, the information will be transmitted within a period of 15 days The competent authority and the MPC. Main judgement criterion: Proportion of patients with renal hematoma when performing of lithotripsy for renal lithiasis, on a 15-day scanner.
Number of topics: 300 based on a 4-step sequential plan of Fleming type
Inclusion criteria:
Patients over 18 years of age benefiting from the social security scheme Patients with at least one renal lithiasis requiring treatment with extracorporeal lithotripsy (ECL)
Non-inclusion criteria:
Coagulation disorder known or discovered on the pre-therapeutic balance sheet Associated anticoagulant therapy. Presence of another contraindications to the ECL.
Conduct of the study:
Study is carried out in current practice at the CHU of Clermont Ferrand in the Department of Urology.
The patient will be seen in consultation by the urologist who shall prescribe the Lithotripsy sessions, inform him about the of the session and will provide him a AFU information sheet concerning the stages of the session, and then, prescribe a blood test to be presented to the lithotriptor on the day of the examination. Not additional accommodation to plan. The patient will return 3 weeks after the ECL session for his evaluation with the urologist. He will have previously completed a blood check and a 15-day scan of the lithotripsy session (instead of about 3 weeks usually).
Benefits and risks of this study:
Simplify patient management under acethylsalicylic acid. Decrease in cardiovascular risk by maintaining the acethylsalicylic acid. Increase of the risk of post-ECL hematoma
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with acethylsalicylic acid 250 mg | Experimental | Other: acetylsalicylic acid (below or equal to) 250 mgProspective single-arm study to estimate the risk of renal hematoma when performing a session of lithotripsy for renal lithiasis, on a 15-day scanner, in patients treated with acetylsalicylic acid not suspended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 yo patients
- Patients with 1 renal lithiasis (at least) requiring treatment with extracorporeal lithotripsy
- Patients taking Kardégic 75 (monotherapy
Key exclusion criteria (5 listed)
- Patients with known (or previously known) bleeding disorders on the pre-treatment assessment
- Patients with anticoagulant therapy or other anti-aggregating therapy (eg Kardegic at 75mg, AVK, NACO, LMWH, HNF, P2Y12 inhibitor)
- Patients with another contrindication to the ECL.
- Patients with prescription of more than the outset 1 ECL session
- Tutelage, curatorship, justice safeguarding, deprived of liberties, unaffiliated SS, impaired comprehension abilities, pregnant and lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicylic acid (below or equal to) 250 mgProspective single-arm study to estimate the risk of renal hematoma when performing a session of lithotripsy for renal lithiasis, on a 15-day scanner, in patients treated with acetylsalicylic acid not suspended. | Other | Patients treated with acethylsalicylic acid 250 mg |
Primary outcome
Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis
Time frame: at 15 days
Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis, on a 15-day scan, in patients under acetylsalicylic acid (below or equal to 250mg) not stopped
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Background: PubMed 9032529Donsimoni R, Hennequin C, Fellahi S, Troupel S, Moel GL, Paris M, Lacour B, Daudon M. New aspects of urolithiasis in France. GERBAP: Groupe d'Evaluation et de Recherche des Biologistes de l'Assistance Publique des Hopitaux de Paris. Eur Urol. 1997;31(1):17-23.
- Background: PubMed 11530173Bihl G, Meyers A. Recurrent renal stone disease-advances in pathogenesis and clinical management. Lancet. 2001 Aug 25;358(9282):651-6. doi: 10.1016/S0140-6736(01)05782-8.
- Background: PubMed 15127165Daudon M, Dore JC, Jungers P, Lacour B. Changes in stone composition according to age and gender of patients: a multivariate epidemiological approach. Urol Res. 2004 Jun;32(3):241-7. doi: 10.1007/s00240-004-0421-y. Epub 2004 May 4.
- Background: PubMed 8632527Streem SB, Yost A, Mascha E. Clinical implications of clinically insignificant store fragments after extracorporeal shock wave lithotripsy. J Urol. 1996 Apr;155(4):1186-90.
- Background: PubMed 8490666Tolley DA. Consensus of lithotriptor terminology. World J Urol. 1993;11(1):37-42. doi: 10.1007/BF00182170.
- Background: PubMed 10671779Candau C, Saussine C, Lang H, Roy C, Faure F, Jacqmin D. Natural history of residual renal stone fragments after ESWL. Eur Urol. 2000 Jan;37(1):18-22. doi: 10.1159/000020093.
- Background: PubMed 16006948Raza A, Turna B, Smith G, Moussa S, Tolley DA. Pediatric urolithiasis: 15 years of local experience with minimally invasive endourological management of pediatric calculi. J Urol. 2005 Aug;174(2):682-5. doi: 10.1097/01.ju.0000164749.32276.40.
- Background: PubMed 22350835Badawy AA, Saleem MD, Abolyosr A, Aldahshoury M, Elbadry MS, Abdalla MA, Abuzeid AM. Extracorporeal shock wave lithotripsy as first line treatment for urinary tract stones in children: outcome of 500 cases. Int Urol Nephrol. 2012 Jun;44(3):661-6. doi: 10.1007/s11255-012-0133-0. Epub 2012 Feb 16.
- Background: PubMed 11956471Rodrigues Netto N Jr, Longo JA, Ikonomidis JA, Rodrigues Netto M. Extracorporeal shock wave lithotripsy in children. J Urol. 2002 May;167(5):2164-6.
- Background: PubMed 12559298Ather MH, Noor MA. Does size and site matter for renal stones up to 30-mm in size in children treated by extracorporeal lithotripsy? Urology. 2003 Jan;61(1):212-5; discussion 215. doi: 10.1016/s0090-4295(02)02128-3.
- Background: PubMed 12544330Al-Busaidy SS, Prem AR, Medhat M. Pediatric staghorn calculi: the role of extracorporeal shock wave lithotripsy monotherapy with special reference to ureteral stenting. J Urol. 2003 Feb;169(2):629-33. doi: 10.1097/01.ju.0000047231.36474.57.
- Background: PubMed 12736749Ozgur Tan M, Karaoglan U, Sozen S, Bozkirli I. Extracorporeal shock-wave lithotripsy for treatment of ureteral calculi in paediatric patients. Pediatr Surg Int. 2003 Aug;19(6):471-4. doi: 10.1007/s00383-003-0961-1. Epub 2003 May 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marlène GUANDALINO, MD study director
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetylsalicylic acid (below or equal to) 250 mg in people with Renal Lithiasis and Antiplatelet, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the proportion of renal hematoma during the production of Lithotripsy for renal lithiasis (time frame: at 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03437057, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.